ConMed Corporation: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Recall number

Z-2469-2026

Recalling firm

ConMed Corporation

Product

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Status

Open, Classified

Initiated

2026-05-14

Posted

2026-06-17

Terminated

not on file

Reason

Potential for overpressure alerts.

Root cause

Process change control

Action

ConMed notified consignees on about 05/14/2026 via emailed and mailed letter titled URGENT: Medical Device Correction. Consignees were made aware of the issue and risk associated with the issue. They were instructed that a replacement AirSeal disposable should be available prior to procedures in order to minimize potential delays. Before initiating insufflation, the user should ensure the tubing is properly connected between the AirSeal tube set and Airseal Access Ports. If the connection cannot be securely tightened and the overpressure alert cannot be resolved, please replace the affected device. Detailed instructions were provided on how to connect the AirSeal tube set and Airseal Access Ports. Consignees were also instructed to review inventory for affected units, place a copy of the provided Instructions for Use, Part No. AS-DIS-IFU, Rev. B with any inventory in possession with an active expiration date, contact all applicable departments and facilities that may have received affected products for awareness, and complete and return the medical device response form. If further information relevant to this issue becomes necessary CONMED will communicate as such. On about 06/04/2026 ConMed expanded their recall to include internationally distributed units. The letter sent included the same instructions.

Quantity

1,668 packs (10,005 eaches)

Distribution

Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .

Lot, serial or model codes

Catalog Number: iAS5-75LP. UDI-DI: 10845854046388. Lot Numbers: 202509294, 202508044, 202505144, 202504014, 202502275, 202512034, 202507014, 202510084, 202412144, 202411065, 202409305, 202406284, 202408014, 202409304, 202506254. *OUS added 06/10/2026 expansion: 202502275, 202509294, 202504014, 202507014, 202505144, 202512034, 202411065, 202508044, 202409305, 202409304, 202408014, 202506254, 202510084, 202412144, 202406284. Manufactured from 14 June 2024 to 12 January 2026.

510(k) numbers

["K143404"]

PMA numbers

not on file

Product code

HIF

Firm FEI

3001451571

Firm city

Utica

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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